U.S. patent number 10,099,890 [Application Number 15/216,109] was granted by the patent office on 2018-10-16 for devices, systems and methods for knot tying.
This patent grant is currently assigned to Medicines360. The grantee listed for this patent is Medicines360. Invention is credited to Nick Brooks, Rob Deckman, Ian Holland, Dave Phasey, Matt Sellars.
United States Patent |
10,099,890 |
Deckman , et al. |
October 16, 2018 |
Devices, systems and methods for knot tying
Abstract
Disclosed is an apparatus or device for making knots in a
flexible element that engages a medical device, such as an IUD, and
associated methods. The knot tying device receives the medical
device in a loading element, and then threads the flexible member
through an aperture of the medical device using a spooling element.
A looping element and knotting element ties the flexible member
into a knot. The devices, systems and methods can create a double
loop surgeon's knot that are reproducible during the manufacturing
process.
Inventors: |
Deckman; Rob (San Bruno,
CA), Holland; Ian (Glasgow, GB), Sellars; Matt
(Warwick, GB), Brooks; Nick (Wellesbourne,
GB), Phasey; Dave (Warwick, GB) |
Applicant: |
Name |
City |
State |
Country |
Type |
Medicines360 |
San Francisco |
CA |
US |
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Assignee: |
Medicines360 (San Francisco,
CA)
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Family
ID: |
57886441 |
Appl.
No.: |
15/216,109 |
Filed: |
July 21, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170029236 A1 |
Feb 2, 2017 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62200051 |
Aug 2, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65H
69/04 (20130101) |
Current International
Class: |
B65H
69/04 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2673230 |
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Jan 2015 |
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EP |
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2012107464 |
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Aug 2012 |
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WO |
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2017023573 |
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Feb 2017 |
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WO |
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Other References
International Search Report in PCT/US2016/043498 dated Oct. 12,
2016. cited by applicant .
Rivera et al., "The Intrauterine Device in the Present and Future",
Dec. 1993, Curr. Opinion Obstet. Gynecol. 5 (6):829-32 [Abstract].
cited by applicant .
Roberts et al., "Scanning electron microscopy of the multifilament
IUD strong", Mar. 1984, Contraception 29:215-228 [Abstract]. cited
by applicant.
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Primary Examiner: Hurley; Shaun R
Assistant Examiner: Nguyen; Bao-Thieu L
Attorney, Agent or Firm: Shartsis Friese, LLP O'Regan;
Cecily Anne
Parent Case Text
CROSS-REFERENCE
This application claims the benefit of U.S. Provisional Application
No. 62/200,051, filed Aug. 2, 2015, entitled Devices, Systems and
Methods for Knot Tying which application is incorporated herein by
reference.
Claims
What is claimed is:
1. An apparatus for forming a knot in a flexible element which has
been threaded through an aperture of a medical device comprising: a
loading element for receiving the medical device; a spooling
element for threading the flexible member through the aperture of
the medical device wherein the spooling element further comprises a
spool spindle, a nip feed and a thread spool and automatically
engages the loading element; a looping element for looping the
flexible member wherein the looping element automatically engages
when the flexible member is threaded through the aperture of the
medical device; a knot tightening element for tightening the looped
flexible member to form the knot wherein the knot tightening
element automatically engages after the looping element loops the
flexible member; and a base wherein the loading element, spooling
element and looping element are positioned on an upper surface of
the base.
2. The apparatus of claim 1 wherein the loading element further
comprises a platform for engaging the medical device wherein the
platform for engaging the medical device integrally forms with a
barrel having a central barrel aperture.
3. The apparatus of claim 1 wherein the looping element further
comprises a winding mandrel.
4. The apparatus of claim 1 wherein the knot tightening element
further comprises a rotary lock and a shaft.
5. The apparatus of claim 1 further comprising a housing wherein
the loading element, spooling element, looping element, knot tying
element and base are positioned within the housing.
6. The apparatus of claim 5 wherein the apparatus is connected to a
vision inspection device.
7. The apparatus of claim 6 wherein the vision inspection device
includes a camera and a medical device loader.
8. A method of forming a knot in a medical device comprising:
loading the medical device into a knotting device wherein the
knotting device has a loading element, a spooling element, a
looping element, a knot tightening element, and a base; passing a
flexible element through an aperture in the medical device while
the medical device engages the spooling element wherein the
spooling element further comprises a spool spindle, a nip feed and
a thread spool; winding a length of the flexible element about the
spool spindle of the spooling element; releasing a first end and a
second end of the flexible element; moving the loading element away
from the looping element; engaging a portion of the wound flexible
element with a hook; applying a tension on the flexible element;
and releasing the hook as the knot forms in the flexible element
adjacent the medical device, wherein the method is performed
automatically or semi-automatically.
9. The method of forming the knot in a medical device of claim 8
further comprising obtaining an image of the formed knot.
10. The method of forming the knot in a medical device of claim 9
further comprising analyzing the image of the formed knot to
determine a dimension and a location of the knot.
11. The method of forming the knot in a medical device of claim 10
further comprising approving the medical device with the knotted
flexible member if the analyzed dimensions detected from the image
of the knot formed are within a dimension range for the knot size
and location.
12. An apparatus for forming a knot in a flexible element which has
been threaded through an aperture of a medical device comprising: a
loading element means for receiving the medical device; a spooling
element means for threading the flexible member through the
aperture of the medical device wherein the spooling element means
further comprises a spool spindle, a nip feed and a thread spool
and automatically engages the loading element means; a looping
element means for looping the flexible member wherein the looping
element means automatically engages when the flexible member is
threaded through the aperture of the medical device; a knot
tightening element means for tightening the looped flexible member
to form the knot wherein the knot tightening element automatically
engages after the looping element means loops the flexible member;
and a base wherein the loading element means, spooling element
means and looping element means are positioned on an upper surface
of the base.
13. The apparatus of claim 12 wherein the loading element means
further comprises a platform for engaging the medical device
wherein the platform for engaging the medical device integrally
forms with a barrel having a central barrel aperture.
14. The apparatus of claim 12 wherein the looping element means
further comprises a winding mandrel.
15. The apparatus of claim 12 wherein the knot tightening element
means further comprises a rotary lock and a shaft.
16. The apparatus of claim 12 further comprising a housing wherein
the loading element means, spooling element means, looping element
means, knot tying element means and base are positioned within the
housing.
17. The apparatus of claim 16 wherein the apparatus is connected to
a vision inspection device means.
18. The apparatus of claim 17 wherein the vision inspection device
means includes a camera and a medical device loader.
Description
BACKGROUND
Knot tying generally requires inserting one end of a wire or string
through a loop formed in the wire to create a knot. Handling of the
wire or string during the knotting process can be relatively
complex--particularly when the wire or string has a small diameter.
Automated knot tying apparatuses have used robotic means where the
wire or string being knotted is held and released at different
points during the knotting process.
As is known in the art, a surgeon's knot is a simple modification
of a reef knot. The surgeon's knot adds an extra twist when tying
the first throw, which results in forming a double overhand knot.
In practice, the additional turn provides more friction and can
reduce loosening while the second half of the knot is tied. This
additional integrity to the knot is an important feature in the
surgical setting. This knot is commonly used by surgeons in
situations where it is important to maintain tension on a
suture.
Devices such as hormonal or copper intrauterine devices (IUD),
which are used as a common method of anti-conception and/or for
treatment of menorrhagia, have a string attached to the device.
After insertion of a T-shaped IUD, the string remains positioned
within the cervix for a period of 3 to 10 years to facilitate
extraction of the IUD by the health care provider. It is customary
to provide the string of an IUD with a knot to securely fasten the
string. However, to facilitate delivery via an inserter and optimal
positioning within the patient's cervix, the knot should be tied so
that the knot is not too close or too far from the IUD or does not
have a profile exceeding an optimal height. The position of the
knot with respect to the IUD and its form and thickness is also
important to ensure compatibility with the IUD insertion device and
to avoid spreading of possible infectious agents such as viruses,
bacteria and fungi from the vaginal region into the uterus, since
it has been observed that said knot can be the thriving place of
infectious agents. See, for example, Roberts at al., 1984,
Contraception 29, Issue 3, pp 215-228; Rivera at al., 1993, Curr.
Opin. Obstet. Gynecol. 5(6):829-32). What are needed are devices
and methods that facilitate reproducible knotting results.
SUMMARY
Disclosed are devices and methods for creating a double loop
surgeon's knot.
An aspect of the disclosure is directed to an apparatus for forming
a knot in a flexible element which has been threaded through an
aperture of a medical device. Suitable apparatuses comprise: a
loading element for receiving the medical device; a spooling
element for threading the flexible member through the aperture of
the medical device wherein the spooling element automatically
engages the loading element; a looping element for looping the
flexible member wherein the looping element automatically engages
when the flexible member is threaded through the aperture of the
medical device; a knot tightening element for tightening the looped
flexible member to form the knot wherein the knot tightening
element automatically engages after the looping element loops the
flexible member; and a base wherein the loading element, spooling
element and looping element are positioned on an upper surface of
the base. Additionally, in some configurations, the loading element
further comprises a platform for engaging the medical device
wherein the platform for engaging the medical device integrally
forms with a barrel having a central barrel aperture. The looping
element can further comprise a winding mandrel. In some
configurations, the knot tightening element can further comprise a
rotary lock and a shaft. Additionally, the spooling element can
further comprise a spool spindle, a nip feed and a thread spool. A
housing can be provided wherein the loading element, spooling
element, looping element, knot tying element and base are
positioned within the housing. Additionally, the apparatus can
engage a vision inspection device. The vision inspection device can
be used to inspect the quality of the knot prior to releasing
device for packaging. Suitable vision inspection devices include a
camera and a device holder.
Another aspect of the disclosure is directed to an apparatus for
forming a knot in a flexible element which has been threaded
through an aperture of a medical device. Suitable apparatuses
comprise: a loading element for receiving the medical device; a
spooling element for threading the flexible member through the
aperture of the medical device wherein the spooling element
automatically or semi-automatically engages the loading element; a
looping element for looping the flexible member wherein the looping
element automatically or semi-automatically engages when the
flexible member is threaded through the aperture of the medical
device; a knot tightening element for tightening the looped
flexible member to form the knot wherein the knot tightening
element automatically or semi-automatically engages after the
looping element loops the flexible member; and a base wherein the
loading element, spooling element and looping element are
positioned on an upper surface of the base. Additionally, in some
configurations, the loading element further comprises a platform
for engaging the medical device wherein the platform for engaging
the medical device integrally forms with a barrel having a central
barrel aperture. The looping element can further comprise a winding
mandrel. In some configurations, the knot tightening element can
further comprise a rotary lock and a shaft. Additionally, the
spooling element can further comprise a spool spindle, a nip feed
and a thread spool. A housing can be provided wherein the loading
element, spooling element, looping element, knot tying element and
base are positioned within the housing. Additionally, the apparatus
can engage a vision inspection device. The vision inspection device
can be used to inspect the quality of the knot prior to releasing
device for packaging. Suitable vision inspection devices include a
camera and a device holder.
Yet another aspect of the disclosure is directed to a method of
forming a knot in a medical device. Suitable methods comprise:
loading the medical device into a knotting device; passing a
flexible element through an aperture in the medical device; winding
a length of the flexible element about a spindle of the knotting
device; releasing a first end and a second end of a flexible
element; moving a first knotting component away from a second
knotting component; engaging a portion of the wound flexible
element with a hook; applying a tension on the flexible element;
and releasing the hook as the knot forms adjacent the medical
device, wherein the method is performed automatically or
semi-automatically. The method of forming the knot in a medical
device can further include obtaining an image of the formed knot.
The image can then be analyzed to determine a dimension and a
location of the knot relative to the body of the medical device.
Additional steps can include processing the device with the
flexible member into an approved container if the analyzed
dimensions are within a dimensional range.
Still another aspect of the disclosure is directed to an apparatus
for forming a knot in a flexible element which has been threaded
through an aperture of a medical device comprising: a loading
element means for receiving the medical device; a spooling element
means for threading the flexible member through the aperture of the
medical device wherein the spooling element means automatically
engages the loading element means; a looping element means for
looping the flexible member wherein the looping element means
automatically engages when the flexible member is threaded through
the aperture of the medical device; a knot tightening element means
for tightening the looped flexible member to form the knot wherein
the knot tightening element automatically engages after the looping
element means loops the flexible member; and a base wherein the
loading element means, spooling element means and looping element
means are positioned on an upper surface of the base. The loading
element means can further comprises a platform for engaging the
medical device wherein the platform for engaging the medical device
integrally forms with a barrel having a central barrel aperture.
Additionally, the looping element means further comprises a winding
mandrel. In some configurations the knot tightening element means
further comprises a rotary lock and a shaft, while the spooling
element means can further comprise a spool spindle, a nip feed and
a thread spool. The entire apparatus or device can be positioned
within a housing enclosing all or a part of the loading element
means, spooling element means, looping element means, knot tying
element means and base. Additionally, the apparatus can be
connected to a vision inspection device means. The vision
inspection device means can include, for example, a camera and a
device holder.
Yet another aspect of the disclosure is directed to an apparatus
for forming a knot in a flexible element which has been threaded
through an aperture of a medical device comprising: a loading
element means for receiving the medical device; a spooling element
means for threading the flexible member through the aperture of the
medical device wherein the spooling element means automatically or
semi-automatically engages the loading element means; a looping
element means for looping the flexible member wherein the looping
element means automatically or semi-automatically engages when the
flexible member is threaded through the aperture of the medical
device; a knot tightening element means for tightening the looped
flexible member to form the knot wherein the knot tightening
element automatically or semi-automatically engages after the
looping element means loops the flexible member; and a base wherein
the loading element means, spooling element means and looping
element means are positioned on an upper surface of the base. The
loading element means can further comprises a platform for engaging
the medical device wherein the platform for engaging the medical
device integrally forms with a barrel having a central barrel
aperture. Additionally, the looping element means further comprises
a winding mandrel. In some configurations the knot tightening
element means further comprises a rotary lock and a shaft, while
the spooling element means can further comprise a spool spindle, a
nip feed and a thread spool. The entire apparatus or device can be
positioned within a housing enclosing all or a part of the loading
element means, spooling element means, looping element means, knot
tying element means and base. Additionally, the apparatus can be
connected to a vision inspection device means. The vision
inspection device means can include, for example, a camera and a
device holder.
INCORPORATION BY REFERENCE
All publications, patents, and patent applications mentioned in
this specification are herein incorporated by reference to the same
extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference. Disclosures related to knot tying
devices include, for example, U.S. Pat. No. 8,936,282 B1 issued
Jan. 20, 2015 to Berdahl for Stop Knot Tying Device; U.S. Pat. No.
8,573,656 B1 issued Nov. 5, 2013, to Zhang for Knot-Tying Device
and Method; U.S. Pat. No. 8,511,722 B1 issued Aug. 20, 2013, to
Farner for Knot Tying Device; U.S. Pat. No. 8,414,035 B2 issued
Apr. 9, 2013, to Bell for System and Method for Providing Knot
Tying; U.S. Pat. No. 6,641,181 B2 issued Nov. 4, 2003, to Thomas
for Automatic Knot-Tying Machine; U.S. Pat. No. 6,419,283 B1 issued
Jul. 16, 2002 to Thomas for Automatic Knot-Tying Machine; U.S. Pat.
No. 5,566,435 A issued Oct. 22, 1996 to Brown Jr. for Method of
attaching a tampon withdrawal cord with an overhand hitch knot;
U.S. Pat. No. 4,836,587 A issued Jun. 6, 1989, to Hinzmann for
Apparatus for Making Knots in Drawstrings of Catamenial Tampons;
U.S. Pat. No. 3,490,801 A issued Jan. 20, 1970 for Knot Tying
Device for Fringes; U.S. Pat. No. 2,873,133 A issued Feb. 10, 1959
to Wieser for Device for Tying a Thread Round an Object and for
Knotting the Thread Ends; US2013/0298361 A1 published Nov. 14,
2013, to Pasteels for Apparatus for Knotting Drawstrings of Medical
Devices or Medical Devices Containing Drugs; US 2007/0203508 A1
published Aug. 30, 2007, to White et al. for Bone Anchor
Suture-Loading System, Method and Apparatus; WO 2012/107464 A1
published Aug. 16, 2012, to Pasteels for Apparatus for Knotting
Drawstrings of Medical Devices or Medical Devices Containing
Drugs.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
FIGS. 1A-G illustrates the process of forming a surgeon's knot;
FIG. 2 illustrates an intrauterine device (IUD);
FIGS. 3A-G illustrate a process of forming a surgeon's knot through
an eyelet of an IUD;
FIGS. 4A-G illustrate another method of forming a surgeon's
knot;
FIGS. 5A-G illustrate a device for forming a surgeon's knot;
FIGS. 6A-C illustrate a barrel suitable for forming a surgeon's
knot;
FIGS. 7A-B illustrate a system for getting a suture or thread
through an eyelet in an IUD;
FIGS. 8A-1, 8A-2, 8B-1, and 8B-2 illustrate a device for forming a
surgeon's knot; FIG. 8C is an exploded view of a winding mandrel;
FIG. 8D is an exploded view of a feed in assembly; FIG. 8E is an
exploded view of a suture guide and spindle; FIG. 8F is an exploded
view of a suture wing tool;
FIGS. 9A-1, 9A-2, 9B-9C, 9D-1, 9-D2, and 9E-9J illustrate a device
for forming a surgeon's knot;
FIGS. 10A-C illustrate suitable knots formed by the device;
FIGS. 11A-Z illustrates the device at different steps in the
process of forming a knot;
FIG. 12 illustrates a machine having the knot-tying device; and
FIG. 13 illustrates an optical automated quality inspect component
which can be integrated into the machine of FIG. 12.
DETAILED DESCRIPTION
FIGS. 1A-G illustrates the process of forming a surgeon's knot 102.
A flexible element 100 such as a thread, a wire, a suture or a
string is formed in a "u" shape as shown in FIG. 1A. The u-shape is
then flipped to form a loop where the thread crosses over itself as
shown in FIG. 1B. An end is then passed through the loop as shown
in FIG. 1C; and then passed through the loop again as shown in FIG.
1D. As shown in FIGS. 1E-1G, when the ends are pulled, a loop is
formed with a double secure knot.
FIG. 2 illustrates a medical device 110 having an eyelet (aperture)
112 at one end through which a flexible element such as a string
passes, such as a t-frame intrauterine device.
FIGS. 3A-G illustrate a method of forming a surgeon's knot 102 on
the end of a medical device 110 having an eyelet 112, such as an
intrauterine device (IUD). The flexible element 100 is formed in a
"u" shape with the string passed through and eyelet 112 in the
medical device 110, and the open end of the flexible element 100
and the medical device 110 held as shown in FIG. 3A. One or more
pins 302 are used to facilitate the positioning of flexible element
100 relative to the device during the knot tying process. The
u-shape of the flexible element 100 is then flipped to form a loop
where the flexible element 100 crosses over itself as shown in FIG.
3B. The IUD is then passed through the loop formed by the flexible
element 100 as shown in FIG. 3C; and then passed through the loop
again as shown in FIG. 3D. The pins holding the loop of the
flexible element 100 open are removed and one pin 302 is placed
next to the IUD inside the loop as shown in FIG. 3E. The flexible
element 100 is then pulled tight to form a knot around the pin next
to the IUD as shown in FIG. 3F. Finally, the pin is removed as the
knot becomes small to leave a finished knot which is positioned
close to the IUD as shown in FIG. 3G.
FIGS. 4A-G illustrate another method of forming a surgeon's knot
102 on the end of a medical device 110 having an eyelet 112, such
as an IUD. As shown in FIG. 4A, the flexible element 100 is passed
through an aperture or eyelet 112 in the medical device 110, and
the two ends of the flexible element 100 are wound around a barrel
420. The medical device 110 is then passed through a barrel
aperture 422 crossing over the open threaded end as shown in FIG.
4B. Once the medical device 110 is passed through the barrel
aperture 422, the medical device 110 is passed over the flexible
element 100 as shown in FIG. 4C. The surgeon's knot 102 is then
slid off of the barrel 420 as shown in FIG. 4D. A pin 424 is then
placed in the surgeon's knot 102 close to the medical device 110 as
shown in FIG. 3E, thereafter the surgeon's knot 102 is tightened
against the pin 424 as shown in FIG. 4F. The pin 424 is then
removed and the surgeon's knot 102 is tightened further as shown in
FIG. 4G. The result is that once tightened the surgeon's knot 102
of the flexible element 100 is positioned a target distance from
the eyelet 112 of the medical device 110.
FIGS. 5A-G illustrate another device for forming a surgeon's knot
102. An eyelet 112 containing medical device 110, such as an IUD,
with a flexible element 100 passed through the eyelet 112 is placed
into a barrel 520 having a central barrel aperture 530 as shown in
FIG. 5A. Thereafter the flexible element 100 is wound two times
around the barrel 520 as shown in FIG. 5B. The flexible element 100
is pulled through the central barrel aperture 530 as shown in FIG.
5C. As shown in FIG. 5D, the surgeon's knot 102 is then formed as
the flexible element 100 is detached from the barrel. A pin 524 is
placed in the surgeon's knot 102 close to the medical device 110 as
shown in FIG. 5F. The pin 524 is then removed and flexible element
100 is tightened as shown in FIG. 5G. This method facilitates
forming a surgeon's knot 102 at a target distance from the end of
the eyelet 112 of the medical device 110--instead of adjacent the
medical device 110. Another process of forming a surgeon's knot
using the components from FIG. 5, includes forming a complete loop
of a flexible element 100 that is passed through an eyelet 112 of a
medical device 110, such as an IUD. The medical device 110 and
flexible element 100 is wound around a barrel 520 twice and then
the medical device 110 is passed through the central barrel
aperture 530 leaving two winds of flexible element 100 around the
exterior of the barrel 520 with an end of the flexible element 100
passing through the central barrel aperture 530 to the eyelet 112
of the medical device 110. Once the medical device 110 is passed
through the central barrel aperture 530, the flexible element 100
positioned around the barrel 520 are slid off the barrel 520. A pin
524 is placed through the winds of the flexible element 100 which
were slid off of the barrel 520 at a position near the eyelet 112.
Tension is placed on the flexible element 100 to begin tightening
the surgeon's knot 102 of the flexible element 100 against the pin
524. As the surgeon's knot 102 nears completion, but before the
tension around the pin 524 is too great, the pin 524 is removed,
and then the final tension is applied to the flexible element 100
to form the surgeon's knot 102.
FIGS. 6A-C illustrate a device retainer 600 which includes a barrel
620 having a device holder 622 configured to hold an eyelet 112
containing device such as a medical device 110. The barrel 620
contains a device holder 622 which can be removable and can have
one or more pins 624 positioned to orient the medical device 110 on
the device holder 622. The medical device 110 is secured within the
device holder 622 on an exterior surface of the device holder 622.
Once the medical device 110 is constrained, the flexible element
100, which has been fed through the eyelet 112 of the medical
device 110, is wound around the barrel arrangement, i.e., the
combination of the barrel 620 and the device holder 622, until 2
full turns of the flexible element 100 around the exterior of the
barrel arrangement are formed. The open ends of the flexible
element 100 are then grabbed by the hook 652 of the knotting tool
650 and the flexible element 100 is pulled through the device
holder 622. The device, such as the medical device 110, is then
pulled away from the device holder 622 and a pin 524 can be
inserted to tighten the surgeon's knot 102 against. The barrel 620
can be used as part of a larger system as shown in FIGS. 8A-1-8F at
800.
FIGS. 7A-B illustrate a system for forming a surgeon's knot using a
grasper 720 and a threader 722 to put a flexible element 100
through an eyelet 112 in the aperture containing medical device
110. The flexible element 100 can be fed through a nip feeder
710.
FIGS. 8A-1-8B-2 illustrate a knot tying device 800 for forming a
surgeon's knot from a top view and a side view. The knot tying
device 800 has several functional components: a device loader which
includes a device retainer 600 (shown in FIG. 6), a
threader/spooler, a loop formation component, and a knot tightening
apparatus. A device removal component can also be provided. The
functional components or apparatus are located on the device in a
device loader area 820 which includes a device retainer 600 (shown
in FIG. 6), a threader/spooler area 840, a loop formation component
area 870, and a knot tightening apparatus area 890.
FIG. 8C is an exploded view of a winding mandrel 842 which is part
of the threader/spooler area 840 shown in FIGS. 8A-1-8B-2. The
winding mandrel 842 is a shaft or cylindrical rod which can be
turned. The winding mandrel 842 has a knotting spindle 844 with a
face 846. A locking tab 848 with a locking tab aperture 849 extends
through a face aperture 847 of the face 846 that is perpendicular
to the walls of the knotting spindle 844. The shaft is
substantially cylindrical. A flange 845 extends from the planar
surface of the face 846. The flange 845 can be configured such that
it extends from the face around a portion of the perimeter and is
shaped similarly to the knotting spindle 844. Where the knotting
spindle 844 forms a circle in cross-section, the flange can extend
and form a "C". Additionally, the flange 845 can be formed from one
or more sections. The flange 845 can have a shaped surface 850
along a surface perpendicular to the face 846 wherein the shaped
surface 850 is configured to conform to a device retainer 600, as
shown also in FIG. 6. In the configuration shown in FIGS. 8A-1-8F,
the medical device 110 fits within the device retainer 600, such
that the medical device 110 sits on a surface of the barrel 620 and
the device holder 622 sits on top of the medical device 110. A
control pin 630 can be provided to engage the barrel 620 with the
device holder 622. Additionally, one or more position stabilizing
pins 632, 634 can be provided to engage the barrel 620 with the
device holder 622 from a perpendicular position to the control pin
630. The device holder 622 can have a device holder aperture 623
which receives a device holder pin 625. Once the device is
positioned within the device retainer 600, the device retainer 600
travels from a position exterior to the outer surface of the
winding mandrel 842 towards the center of the winding mandrel 842
until the device retainer 600 engages the locking tab aperture 849
of the locking tab 848. The device retainer 600 can be positioned
along the shaped surface 850 of the flange 845 on a first surface.
A mating element 851 can be provided to secure the device retainer
600 securely against the shaped surface 850 of the flange 845.
FIG. 8D is an exploded view of a feed in assembly 852 which is part
of the threader/spooler area 840 shown in FIG. 8A-2. The feed in
assembly 852 has a suture spool 853 which engages a feed assembly
plate 854 utilizing one or more compression springs 855 which
surround a suture spool spindle 856 that passes through the central
lumen in the suture spool 853. A spindle securement 857 engages the
suture spool 853, or spindle, to ensure that the suture spool 853
remains in tensioned engagement with the feed assembly plate 854. A
roller plate 858 is provided adjacent the suture spool 853 parallel
to the feed assembly plate 854. The roller plate 858 has a
plurality of shafts 859 in engagement with its surface. Ceramic
tube guides 861, 861' are provided to guide the suture and minimize
wear. A sleeve 862 can be provided through which a hypodermic
needle 863 passes. The sleeve 862 can be formed from any suitable
material including, for example, polytetrafluoroethylene (PTFE).
The hypodermic needle 863 can pass through a portion of the roller
shafts 860. A drive belt 871 is provided. When the drive belt 871
is turned, the shafts 859 and roller shafts 860 turn.
FIG. 8E is an exploded view of a suture guide and spindle. The
suture guide and spindle has a winding spindle 872 which engages a
spooling housing 873. A spindle brake 874 is provided which
controls the speed at which the winding spindle 872 rotates. A
first end of the winding spindle 872 has a spindle washer 864 which
engages a spindle trap pin 865. The opposing end of the winding
spindle 872, after passing through a spooling housing aperture 875
in the spooling housing 873, engages a knob 867. A suture guide 868
is provided which engages the guide block 866.
FIG. 8F is an exploded view including a suture wing tool barrel 821
which engages a follower female barrel 822. An eccentric adjustor
823 fits within a portion of the suture wing tool barrel 821 and
engages a tension eccentric 824 which slides through an off center
aperture 825 in the suture wing tool barrel 821. A connector 826
engages a hook finger 827. The hook finger 827 can take a variety
of forms as shown in FIGS. 9E-H. A torsion spring 828 and PTFE
sleeve 829 can also be provided to maintain tension.
FIGS. 9A-1-9J illustrate the knot tying device 800 for forming a
surgeon's knot. FIG. 9A-2 is a top view of the knot tying device
800 shown in FIG. 8A-1-8F. FIG. 9B is cross-section view of 9B-9B
from FIGS. 9A-1. A leg 910 with a foot 912 supporting the platform
920. On the platform 920, or base, is a portion of the knot
tightening apparatus area 890 from FIG. 8A-1-8F. An end carrier 930
engages the platform 920. The end carrier 930 engages an anchor
disk 932 and a linear shaft 940. A shaft collar and set screw 942
secures a winding stub shaft 944 with a flanged bushing 946. FIG.
9C is a view of 9C-9C of FIG. 9A-2. FIG. 9C illustrates the rotary
block 950. FIGS. 9D-1-9D-2 is a side view of the knot tying device
800. FIGS. 9E-H illustrate configurations of hook 652 which can be
used in the knot tying device 800. The hook 652 can take a variety
of configurations shown in profile as, for example, curved (FIG.
9E), perpendicular (FIG. 9F), double curved (FIG. 9G), and double
perpendicular (FIG. 9H).
FIG. 9I is a perspective view of a knot tying device 800 of FIGS.
8A-1-8F with a loop formation component area 870, a
threader/spooler area 840 component, a knot tightening apparatus
area 890, and a suture wing tool barrel 821 which includes a device
retainer which can be loaded into the system. The suture spool 853
provides a source for a flexible member. A follower block mount 951
engages the knot tightening apparatus area 890 and has a bearing
clamp plate 976 on one side. The follower block mount 951 engages
the rotary block 950. A flanged bushing 946 is provided through
which a linear shaft 940 passes. The follower female barrel 822 is
adjacent the suture wing tool barrel 821. A follower block mount
plate 960 is provided between the platform 920 and the follower
block mount 951. An indexing plunger 962 can be provided to secure
the follower block mount plate 960 to the platform 920. A stopper
956 is provided in communication with a locator block 958. FIG. 9J
shows the knot tying device 800 from a bottom surface.
FIGS. 10A-C illustrates a plurality of surgeon's knots 102 in the
flexible element 100 formed by the knot tying device 800 (FIGS.
8A-1-9J) which engage the eyelet 112 of the medical device 110. The
distance between an end of the medical device 110 and the beginning
of the surgeon's knot 102 is greater than 0.5 mm, the distance
between the end of the medical device 110 and the end of the
surgeon's knot 102 away from the end of the medical device 110 is 7
mm or less. The thickness of the surgeon's knot 102 at its thickest
location is 1.5 mm or less.
When the medical device 110 has been knotted it is removed from the
knot tying device 800 the flexible element 100 may be kinked due to
the clamping mechanism used to hold the loose ends of the flexible
element 100 in place during the knotting process. A length of
flexible element 100 extends past where the flexible element 100 is
clamped during the knotting process. The loose ends of the flexible
element 100 may be released once the surgeon's knot 102 has been
completed. Tension and/or heat can be applied to "stretch out" some
of the coil memory from the spool.
In operation, when the device retainer (which holds the device) is
lowered into a knotting position and the knotting components, the
winding mandrel and knotting spindle, are moved together. The
flexible element passes from the feed assembly into the eyelet of
the medical device held by the barrel. The t-frame of the medical
device can be held vertically within the tube (at a 90 degree angle
from what is shown in FIG. 6). Once the knotting components are
engaged, the device winds the flexible member onto the knotting
spindle. This process transfers the flexible element from the
winding spindle to the knotting spindle as the two spindles turn.
Thereafter, the end of the flexible element is clamped and the ends
of the flexible element are released. The spindle is then rotated
to orient the medical device to vertical, a plunger and knotting
pin are inserted and the knotting components are separated. As the
knotting components are separated, the suture is pulled into a knot
formation. A hook is positioned to engage the thread and to release
as the knot is positioned optimally with respect to the end of the
medical device. The plunger is lowered to the device head then the
knotting pin is removed. The ends of the suture are released and
the plunger is removed. The device retainer is positioned in line
with the linear shaft.
The device is configurable to tie a double loop type surgeons' knot
through an IUD device eyelet at a rate of 5 knots per minute, more
preferably 7 knots per minute. In operation a knot is completed
less than 12 mm away from the end of the IUD, more preferably less
than 10 mm away from the end of the IUD, and even more preferably 7
mm away from the end of the IUD. Once tied, the resulting knot
allows the IUD to move freely in any direction. The completed knot
has an outer diameter less 2.0 mm, more preferably less than 1.75
mm, and even more preferably less than 1.5 mm. Typically more than
200 mm of thread extend beyond the knot on each loose end, more
preferably more than 250 mm of thread extend beyond the knot and
even more preferably 300 mm of thread extend beyond the knot on
each loose end.
Use of the knot tying device, allows a surgeon's knot to be tied
without an operator touching the suture during the knotting
process. Additionally, the knot tying device can be manually loaded
and unloaded. Additionally, the device is sized to fit on a bench
or to be free standing, typically having a profile of 2 ft.times.5
ft.times.5 ft.
Turning to FIGS. 11A-Z, operation of the knot tying device 800 is
illustrated at different steps in the process of forming a
surgeon's knot 102 from a flexible element 100 with a focus on the
area around the winding mandrel 842 and the winding spindle 872.
Initially, a needle 1102 for feeding the flexible element 100 is
moved into position (FIGS. 11A-B). Then the device head restrainer
is put into position (FIG. 11C). The flexible element 100 is wound
through the winding mandrel 842 (FIG. 11D) and then pressure on the
nip feed 1110 area is released 11E. The flexible element 100 is
wound onto the winding mandrel 842 (FIG. 11G), and then the device
retainer 600 is lowered to a knotting position (FIG. 11H-I). The
knotting components are then moved together at which point the
flexible element 100 is wound onto the knotting spindle 844 (FIGS.
11J-L). The knotting spindle 844 turns clockwise while the flexible
element 100 is wound around the knotting spindle 844 (FIGS. 11M-N),
and then the end of the flexible element 100 is clamped (FIG. 11O)
at which point the end of the flexible element 100 is released
(FIG. 11P-Q). As the plunger 1112 is moved inward (FIG. 11R) the
knotting spindle 844 rotates clockwise, when the plunger 1112 moves
outward (FIG. 11S) the knotting spindle 844 rotates
counterclockwise. The plunger 1112 is inserted (FIG. 11T) and the
knotting components are separated (FIG. 11U). As the knotting
components separate, the flexible element 100 engages a hook 652
which facilitates creation of a surgeon's knot as the two knotting
components move away from each other (FIGS. 11V-X). The plunger
1112 is lowered and the knotting pin is removed (FIG. 11Y). The
final position of the knot 102 is adjacent the medical device 110
(FIG. 11Z). As will be appreciated by those skilled in the art, the
steps engaged by the device can be manual, semi-automatic or fully
automatic. Where the device is semi-automatic or fully automatic, a
suitable power supply is provided. Additional components such as
computing systems, controllers, drivers, and the like can be
provided.
The systems and methods described herein may rely on a variety of
computer systems, networks and/or digital devices for operation. As
will be appreciated by those skilled in the art, a computer
readable medium can be employed that stores computer data, which
data can include computer program code that is executable by a
computer, in machine readable form. By way of example, and not
limitation, a computer readable medium may comprise computer
readable storage media, for tangible or fixed storage of data, or
communication media for transient interpretation of code-containing
signals. Computer readable storage media, as used herein, refers to
physical or tangible storage (as opposed to signals) and includes
without limitation volatile and non-volatile, removable and
non-removable storage media implemented in any method or technology
for the tangible storage of information such as computer-readable
instructions, data structures, program modules or other data.
Computer readable storage media includes, but is not limited to,
RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory
technology, CD-ROM, DVD, or other optical storage, magnetic
cassettes, magnetic tape, magnetic disk storage or other magnetic
storage devices, or any other physical or material medium which can
be used to tangibly store the desired information or data or
instructions and which can be accessed by a computer or
processor.
Some embodiments may be implemented in one or a combination of
hardware, firmware and software. Embodiments may also be
implemented as instructions stored on a non-transitory
computer-readable storage medium, which may be read and executed by
at least one processor to perform the operations described herein.
A non-transitory computer-readable storage medium may include any
mechanism for storing information in a form readable by a machine
(e.g., a computer). For example, a non-transitory computer-readable
storage medium may include read-only memory (ROM), random-access
memory (RAM), magnetic disk storage media, optical storage media,
flash-memory devices, and other non-transitory media.
FIG. 12 illustrates a machine 1200 having the knot-tying device
incorporated into a housing. The housing 1202 can, for example, be
used to maintain a sterile environment during the knotting
process.
FIG. 13 illustrates an optical automated quality inspection
component 1300 which can be integrated into the housing containing
the knotting device of FIG. 12. The optical automated quality
inspection component 1300 can have a camera 1310, a cage 1320 and a
loader 1330 which accepts one device at a time after the knotting
process. The quality inspection system takes a picture of the IUD
with the flexible member knotted thereon and determines if the knot
is positioned within a determined distance from the IUD and has a
knot thickness within a determined range. If the knot is within
range, the knotted IUD is passed to a QC passed vessel, if the knot
is not within range, then the knotted IUD is passed to a QC fail
vessel.
As will be appreciated by those skilled in the art a plurality of
washers, screws (such as socket head cap screws), plungers, clamps,
bolts, nuts, brackets, pulleys, panels, and the like can be used in
an embodiment of the disclosed apparatuses, devices and systems
without departing from the scope of the disclosure.
While preferred embodiments of the present invention have been
shown and described herein, it will be obvious to those skilled in
the art that such embodiments are provided by way of example only.
Numerous variations, changes, and substitutions will now occur to
those skilled in the art without departing from the invention. It
should be understood that various alternatives to the embodiments
of the invention described herein may be employed in practicing the
invention. It is intended that the following claims define the
scope of the invention and that methods and structures within the
scope of these claims and their equivalents be covered thereby.
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